(191 days)
Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing
Not Found
This document (K230268) is an FDA 510(k) clearance letter for the ZenPro 40 device, a laser surgical instrument. It outlines the device's indications for use and confirms its substantial equivalence to predicate devices. However, this letter does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria.
The information requested in your prompt typically comes from the technical documentation or a clinical study report submitted to the FDA as part of the 510(k) application, which is not included in this clearance letter.
Therefore, I cannot provide the details you've asked for based on the provided text. To answer your questions, one would need access to the actual submission or summaries of the performance data that were part of the 510(k) application for the ZenPro 40.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.